Design & Implimentation of Compliant Quality Systems for Pharmaceutical, Biologics, Medical Device a

Venue: Hilton Toronto Airport

Location: Mississauga, Ontario, Canada

Event Date/Time: Oct 31, 2005 End Date/Time: Nov 01, 2005
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Description

Practical Guide for Building a Well Structured Quality System and complying with Regulatory requirements

A ONE & HALF DAY COMPREHENSIVE AND INTERACTIVE COURSE, CASE STUDIES AND WORKSHOP ON:

Quality System Standards:
- Quality Systems Approach to cGMP Regulations: CDRH-QSR, CDER-GMPs
- Health Canada, Regulations
- ICH Q7
- EN ISO 9001 Quality Management System (QMS)
Quality System Requirements
Design and Development of Quality Systems
Implementing Quality Systems
Auditing Quality Systems
Deviation Management
Risk Management and Quality Systems
Quality Improvement and Preventive Action
Quality System Records
Statistical Techniques (Quality System Reg. 820.250 and ISO 4.20)
Hazard Analysis & Critical Control Points (HACCP)

WORKSHOP ON:

- Case Studies on past experiences in the Inspecting of Quality Systems
- Quality system performance measurements

DISTINGUISHED SPEAKERS & MODERATORS

Mr. Thomas Feyerabend
Mr. Stephen Haight
Mr. Dave Lowry

Who Should Attend?

This program is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

- Quality Assurance
- Quality Control
- Regulatory Affairs
- Auditing
- Validation Services
- Documentation and Technical Writing
- Product Development
- Product Submission
- API
- Manufacturing
- Training
- GMP/GLP Compliance
- Product Submission
- Contract Laboratories
- Consultants
- Contract manufacturing

Venue

5875 Airport Road
Mississauga
Ontario
Canada
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